Manufacturing Scientist

• Represent Operation in design teams
• fulfill design transfer responsibilities for new and on market product development, validation, and market release phases.
• Lead and assist in sustaining engineering projects for improvement of manufacturing processes, cleaning processes, stability methods, test methods, product specifications, process/test equipment/fixtures, analysis tools, and Enterprise Resource Planning.
• Lead and assist in design input and implementation oversight of infrastructure improvement projects.
• Identify and drive opportunities for process innovations, improvement, and cost reductions.
• Participate and drive development and implementation of process automation strategies and solutions.
• Assume full ownership of sustaining support for on-market processes
• Participate in product feasibility collaborations with R&D, as needed.
• Lead and assist in engineering change control and document change control activities
• participate in change control reviews.
• Collaborate with R&D on the development of material specifications, manufacturing processes, test methods, analysis tools, work instructions and related acceptance criteria for new or on market product Prototype release.
• Assume full design transfer ownership for Production and Market release of material specifications, manufacturing processes, test methods, analysis tools, work instructions and related acceptance criteria for new or on market product.
• Assist in design input and implementation oversight of infrastructure improvement projects.
• Establish and maintain standard architecture of BOMs and routings related to new or existing Reagent Operation processes in Enterprise Resource Planning
• Interface with Cost Accounting for new or existing product COGs roll-up
• Perform cost/benefit analysis for product/process improvement projects
• Collaborate with R&D on OQ process validation planning and execution.
• Assume full ownership of PQ process validation planning, execution, and reporting
• collaborate with R&D as required.
• Assume full ownership of test method and analysis tool validation planning, execution, and reporting
• collaborate with R&D as required.
• Assume full ownership of equipment and test fixture validation planning, execution, and reporting
• collaborate with R&D as required.
• Ensure effective training of Manufacturing and Quality Control personnel for transfer of new processes.
• Responsible for knowledge transfer new product designs being transferred into Operations.
• Develop product stability plans, protocols, and reports.
• Provide training and oversight for stability study execution.
• Drive the administration of the Reagent Stability Program
• identify gaps
• Lead and assist the investigation and resolution of findings impacting the organization identified through audits, non-conformances, corrective/preventative actions, or customer complaint escalation.
• Identify processes requiring statistical process control and implement control charts via Control Charting Program
• Assist in establishing annual goals and objectives
• fulfill individual goals and objectives
• Lead or participate in the development and implementation of new departmental initiatives, policies, and programs.
• Participate in or conduct applicable departmental, interdepartmental and intra-departmental training.
• Ensure personal compliance and influence sectional compliance with the Quality System and other regulations.
• Ensure personal safety compliance and influence sectional safety compliance
• Lead and assist external design transfers and contract manufacturing scenarios.
• Provide packaging and labeling design support to R&D.
• Identify processes for potential improvement and drive/lead Lean Six Sigma project to resolve the issue or inefficiency
• Ensure compliance to NFPA, OSHA, lock-out, and other applicable safety standards.
• Ensure adherence hazardous waste disposal and gowning requirements.
• Other duties as assigned.

• Bachelor's Degree Bachelors of Science (or advanced degree) in the field of Chemistry/Chemical Engineering, Microbiology, Life Sciences, Biomechanical Engineering required
• 8+ Years reagent Operations experience in a relevant ISO 13485:2003 and/or FDA regulated setting. Required
• 5+ Years experience servicing reagent Operations with process improvement, and/or sustaining engineering, and/or design transfer in a Life Sciences, Chemistry, Biomechanical, or Medical Technology field. Required
• 1+ Years Experience working independently or as a team member in a fast-paced environment with rapidly changing priorities required
• Thorough knowledge of ISO 13485 and FDA Quality System requirements
• Proficiency in Enterprise Resource Planning, including applied knowledge of engineering functionality and familiarity with Manufacturing Execution Systems
• Proficiency in the use of Product Lifecycle Management, including applied knowledge of Engineering Change Control
• Applied knowledge of Process and Test Method Validations as required by FDA Quality System guidelines
• Knowledge of Design Control requirements as defined by the FDA Quality System guidelines
• Proven expertise in automation solutions for high complexity, high product mix, small/large run production environment with batch processing up to 2000 Liters
• Proven expertise in design and implementation of infrastructure improvements
• Proven results through application of Six Sigma and Lean Manufacturing principles, including applied knowledge of statistical design of experiments
• Mathematics and statistics aptitude.
• Data analysis and technical writing aptitude.
• Excellent oral and written communication skills.
• Proficient in Microsoft Word, Excel, and PowerPoint programs.
• Highly organized with proven time management and prioritization skills
• Ability to work independently and with minimal supervision
• Ability to handle the pressure of meeting tight deadlines

Certified Quality Engineer (CQE) preferred but not required

Receive a competitive salary and benefits package as you grow your career at Diasorin.